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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CLEARFIL MAJESTY™ ES Flow Universal - EKUR004622KA1

Super Low (U) TRIAL
KURARAY NORITAKE DENTAL INC.
#4622-KA
In Commercial Distribution

  • EKUR004622KA1 ()


  • Dental composite resin

CARDINAL HEALTH - 10195594875923

KIT,VASCULAR U BAR
Cardinal Health 200, LLC
PVOCAACO9
In Commercial Distribution

  • 50195594875921 ()
  • 10195594875923 ()
PVOCAACO9

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

3M™ Unitek™ - 00652221114518

3M™ Unitek™ Nitinol Classic Archwire 9293-913, OrthoForm™ III Ovoid, U 018X025 H U/U PK10
3M UNITEK CORPORATION
9293-913
In Commercial Distribution

  • 80652221114514 ()
  • 00652221114518 ()
9293-913

  • Orthodontic archwire

Esthet-X®flow Liquid Micro Hybrid - D0026481151

Esthet-X®flow Liquid Micro Hybrid, U, 20 Compula® Tips Refill Package
DENTSPLY INTERNATIONAL INC.
648115
In Commercial Distribution

  • D0026481151 ()
  • D0026481150 ()

  • Esthet-X®flow Liquid Micro Hybrid U, 20 Compula® Tips
  • Weight: 0.25 Gram
648115

  • Dental composite resin

Damon - 00889989080483

+ DAMON CLR SPK U/L 5-5 STD-TQ W. CLR U/L 3-3
ORMCO CORPORATION
740-1407
In Commercial Distribution

  • 00889989080483 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic

Damon - 00889989080476

+ DAMON CLR SPK U/L 7-7 STD-TQ W. CLR U/L 3-3
ORMCO CORPORATION
740-1406
In Commercial Distribution

  • 00889989080476 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic

123-Smile - 00860006415495

No Description
U Smile Dental LLC
Spanish
In Commercial Distribution

  • 00860006415495 ()


  • Dental impression material kit, single-use

123-Smile - 00860006415488

No Description
U Smile Dental LLC
12021
In Commercial Distribution

  • 00860006415488 ()


  • Dental impression material kit, single-use

bFed™ - 00867622000456

bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2002
In Commercial Distribution

  • 00867622000456 ()
  • 00867622000470 ()
SK-2002

  • Enteral feeding kit, adult/paediatric, non-sterile

bFed™ - 00867622000449

bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2001
In Commercial Distribution

  • 00867622000449 ()
  • 00867622000463 ()
SK-2001

  • Enteral feeding kit, adult/paediatric, non-sterile

Bolink(TM) - 00867622000418

Large Cap Gravity Feeding Set with ENFit Connector
U DELIVER MEDICAL L.L.C.
1405
In Commercial Distribution

  • 00867622000418 ()
  • 10867622000415 ()
1405

  • Enteral feeding kit, adult/paediatric, non-sterile

Bolink(TM) - 00867622000401

Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
1085
In Commercial Distribution

  • 00867622000401 ()
  • 10867622000408 ()
  • 20867622000405 ()
1085

  • Enteral feeding kit, adult/paediatric, non-sterile

Bolink® - 00860136002466

D Cap Gravity Feeding Set with ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2260
In Commercial Distribution

  • 00860136002466 ()
  • 00860136002473 ()


  • Enteral feeding noninvasive-component set

Bolink™ - 00860136002435

Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2085
In Commercial Distribution

  • 00860136002435 ()
  • 10860136002425 ()
BK-2085

  • Enteral feeding kit, adult/paediatric, non-sterile

Bolink™ - 00860136002428

Large Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2405
In Commercial Distribution

  • 00860136002428 ()


  • Enteral feeding kit, adult/paediatric, non-sterile

Protect U Guard Non-Woven Dressing - B086291222

Protect U Guard Non-Woven Dressing 9x30 cm
PROTECT U GUARD, LLC
P19122
In Commercial Distribution

  • B086291222 ()
  • B086091220 ()

  • Width: 9 Centimeter
  • Length: 30 Centimeter


  • Adhesive bandage

Protect U Guard Non-Woven Dressing - B086291212

Protect U Guard Non-Woven Dressing 9x20cm
PROTECT U GUARD, LLC
P29121
In Commercial Distribution

  • B086291212 ()
  • B086091210 ()

  • Width: 9 Centimeter
  • Length: 20 Centimeter


  • Adhesive bandage

Protect U Guard Non-Woven Dressing - B086291202

Protect U Guard Non-Woven Dressing 7x9cm
PROTECT U GUARD, LLC
P29120
In Commercial Distribution

  • B086291202 ()
  • B086091200 ()

  • Width: 7 Centimeter
  • Length: 9 Centimeter


  • Adhesive bandage

Protect U Guard Isolation Gown 30 GSM Yellow - B086205022

No Description
PROTECT U GUARD, LLC
P20502
In Commercial Distribution

  • B086205022 ()
  • B086205020 ()


  • Isolation gown, single-use

Protect U Guard Isolation Gown 20 GSM Yellow - B086205012

No Description
PROTECT U GUARD, LLC
P20501
In Commercial Distribution

  • B086205012 ()
  • B086205010 ()


  • Isolation gown, single-use

Protect U Guard Shoe Cover With Anti Skid - B086204012

No Description
PROTECT U GUARD, LLC
P20401
In Commercial Distribution

  • B086204012 ()
  • B086204010 ()


  • Shoe cover, non-conductive, sterile

Protect U Guard Doctor Cap Blue - B086203012

No Description
PROTECT U GUARD, LLC
P20301
In Commercial Distribution

  • B086203012 ()
  • B086203010 ()


  • Surgical cap, single-use

Protect U Guard Bouffant Cap Yellow - B086202022

No Description
PROTECT U GUARD, LLC
P20202
In Commercial Distribution

  • B086202022 ()
  • B086202020 ()


  • Surgical cap, single-use

Protect U Guard Bouffant Cap Blue - B086202012

No Description
PROTECT U GUARD, LLC
P20201
In Commercial Distribution

  • B086202012 ()
  • B08620210 ()


  • Surgical cap, single-use

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove - B086201142

Nitrile Patient Examination Glove, White, Extra Large
PROTECT U GUARD, LLC
P20114
In Commercial Distribution

  • B086201142 ()
  • B086101140 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove - B086201132

Nitrile Patient Examination Glove, White, Large
PROTECT U GUARD, LLC
P20113
In Commercial Distribution

  • B086201132 ()
  • B086101130 ()

  • Large


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove - B086201122

Nitrile Patient Examination Glove, White, Medium
PROTECT U GUARD, LLC
P20112
In Commercial Distribution

  • B086201122 ()
  • B086101120 ()

  • Medium


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove - B086201112

Nitrile Patient Examination Glove, White, Small
PROTECT U GUARD, LLC
P20111
In Commercial Distribution

  • B086201112 ()
  • B086101110 ()

  • Small


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove - B086201042

Nitrile Patient Examination Glove, Indigo, Extra Large
PROTECT U GUARD, LLC
P20104
In Commercial Distribution

  • B086201042 ()
  • B086101040 ()

  • Extra Large


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Protect U Guard Nitro-Lion Nitrile Patient Examination Glove - B086201032

Nitrile Patient Examination Glove, Indigo, Large
PROTECT U GUARD, LLC
P20103
In Commercial Distribution

  • B086201032 ()
  • B086101030 ()

  • Large


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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